基于标准汤剂的苦地丁配方颗粒质量标准研究  

Quality Standard of Corydalis bungeana Formula Granules Based on Standard Decoction

作　　者：贾扬花 史国华 韩君 高瑞林 张志强 JIA Yanghua;SHI Guohua;HAN Jun;GAO Ruilin;ZHANG Zhiqiang(Beijing Tcmages Pharmaceutical Co.,Ltd.,Beijing 101301,China;National and Local Joint Engineering Research Center for Key Technologies of Chinese Medicinal Composition Granules,Beijing 101301,China;Beijing Engineering Technology Research Center for Chinese Medicinal Composition Granules,Beijing 101301,China)

机构地区：[1]北京康仁堂药业有限公司,北京101301 [2]中药配方颗粒关键技术国家地方联合工程研究中心,北京101301 [3]北京市中药配方颗粒工程技术研究中心,北京101301

出　　处：《中国现代中药》2025年第1期145-151,共7页Modern Chinese Medicine

摘　　要：目的:建立以标准汤剂为对照的苦地丁配方颗粒质量标准。方法:按《中药配方颗粒质量控制与标准制定技术要求》规范,制备23批苦地丁标准汤剂,构建表征物质基础全成分的高效液相色谱法特征图谱,测定出膏率、紫堇灵含量及转移率。以标准汤剂物质基础为基准,制备3批苦地丁配方颗粒并验证工艺的合理性。结果:特征图谱8个共有峰中峰5~峰8分别为延胡索乙素、紫堇灵、乙酰紫堇灵、N-反式阿魏酰酪胺,该方法专属性强,可鉴别混淆品。苦地丁出膏率为18.0%~34.0%,紫堇灵质量分数为1.5~4.0 mg·g^(−1)、转移率为25.0%~48.0%。配方颗粒出膏率为27.0%~27.6%,紫堇灵质量分数为1.8~2.5 mg·g^(−1)、转移率为34.6%~45.6%,均在标准规定范围内,且各指标及8个特征峰量值传递均与同批标准汤剂接近。结论:建立的质量标准可确保配方颗粒与标准汤剂的高度相关性,可为苦地丁配方颗粒质量控制及工艺研究提供参考。Objective:To establish the quality standard of Corydalis bungeana Turcz.formula granules based on the standard decoction and provide a reference for the quality control of the formula granules.Methods:According to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules,23 batches of C.bungeana Turcz.standard decoction were prepared,and the high performance liquid chromatography(HPLC)characteristic chromatogram that could fully characterize the material components was constructed.The extraction rate,as well as the content and the transfer rate of corynoline were determined.Based on the material basis of standard decoction,three batches of C.bungeana Turcz.formula granules were prepared,and the rationality of the process was verified.Results:Among the eight common peaks of the characteristic spectrum,peaks 5,6,7,and 8 were tetrahydropalmatine,corynoline,acetylcorynoline,and N-trans-feruloyltyramine.They had strong specificity and could identify adulterants.The extraction rate of the standard decoction was 18.0%-34.0%,and the mass fraction of corynoline was 1.5-4.0 mg·g^(−1),with a transfer rate of 25.0%-48.0%.The extraction rate of the formula granules was 27.0%-27.6%,and the mass fraction of corynoline was 1.8-2.5 mg·g^(−1),with a transfer rate of 34.6%-45.6%.These indicators were within the scope of the standard,and all the indicators and the quantity value passing of the eight characteristic peaks were close to the same batch of standard decoction.Conclusion:The established quality standard can ensure the high correlation between the formula granule and the standard decoction and provide a reference for the quality control and process research of C.bungeana Turcz.formula granules.

关 键 词：苦地丁 标准汤剂 配方颗粒 质量标准 紫堇灵 特征图谱 

分 类 号：R282[医药卫生—中药学]